Department of Sports Medicine, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.
JAMA Netw Open. 2024 May 1;7(5):e2410134. doi: 10.1001/jamanetworkopen.2024.10134.
IMPORTANCE: Platelet-rich plasma (PRP) has been considered a promising treatment for musculoskeletal disorders. The effects of PRP on clinical outcomes of anterior cruciate ligament reconstruction (ACLR) are controversial. OBJECTIVE: To compare subjective outcomes and graft maturity in patients undergoing ACLR with and without postoperative intra-articular PRP injection. DESIGN, SETTING, AND PARTICIPANTS: This surgeon- and investigator-masked randomized clinical trial included patients treated at a national medical center in China who were aged 16 to 45 years and scheduled to undergo ACLR. Participants were enrolled between March 21, 2021, and August 18, 2022, and followed up for 12 months, with the last participant completing follow-up on August 28, 2023. INTERVENTIONS: Participants were randomized 1:1 to the PRP group (n = 60), which received 3 doses of postoperative intra-articular PRP injection at monthly intervals, or to the control group (n = 60), which did not receive postoperative PRP injection. Both groups had the same follow-up schedule. MAIN OUTCOMES AND MEASURES: The primary outcome was the mean score for 4 subscales of the Knee Injury and Osteoarthritis Outcome Score (KOOS4) (range, 0-100, with higher scores indicating better knee function and fewer symptoms) at 12 months postoperatively. Secondary outcomes were patient-reported outcomes, graft maturity (on magnetic resonance imaging), and physical examinations at 3, 6, and 12 months. RESULTS: Among the 120 randomized participants (mean [SD] age, 29.0 [8.0] years; 84 males [70%]), 114 (95%) were available for the primary outcome analysis. The mean KOOS4 scores at 12 months were 78.3 (SD, 12.0; 95% CI, 75.2-81.4) in the PRP group and 76.8 (SD, 11.9; 95% CI, 73.7-79.9) in the control group (adjusted mean between-group difference, 2.0; 95% CI, -2.3 to 6.3; P = .36). Secondary outcomes were not statistically significantly different between the 2 groups except for sports and recreation level and graft maturity at 6 months. Intervention-related adverse events included pain at the injection site and knee swelling after injection. CONCLUSIONS AND RELEVANCE: In this randomized clinical trial among patients undergoing ACLR, the addition of postoperative intra-articular PRP injection did not result in superior improvement of knee symptoms and function at 12 months compared with no postoperative injection. Further studies are required to determine appropriate indications for PRP in musculoskeletal disorders. TRIAL REGISTRATION: Chinese Clinical Trial Registry Identifier: ChiCTR2000040262.
重要性：富含血小板的血浆（PRP）被认为是治疗肌肉骨骼疾病的一种有前途的治疗方法。PRP 对前交叉韧带重建（ACLR）的临床结果的影响存在争议。
目的：比较接受和不接受术后关节内 PRP 注射的 ACLR 患者的主观结果和移植物成熟度。
设计、地点和参与者：这是一项由外科医生和研究员进行盲法随机临床试验，纳入了在中国一家国家医疗中心接受治疗的年龄在 16 至 45 岁之间、计划接受 ACLR 的患者。参与者于 2021 年 3 月 21 日至 2022 年 8 月 18 日期间入组，并随访 12 个月，最后一名参与者于 2023 年 8 月 28 日完成随访。
干预措施：参与者按照 1:1 的比例随机分为 PRP 组（n = 60），术后每月接受 3 次关节内 PRP 注射，或对照组（n = 60），不接受术后 PRP 注射。两组都有相同的随访计划。
主要结果和测量指标：主要结局是术后 12 个月时膝关节损伤和骨关节炎结果评分（KOOS4）的 4 个亚量表的平均评分（范围，0-100，得分越高表示膝关节功能越好，症状越少）。次要结局是患者报告的结果、移植物成熟度（磁共振成像）和 3、6 和 12 个月时的体格检查。
结果：在 120 名随机参与者（平均[标准差]年龄，29.0[8.0]岁；84 名男性[70%]）中，有 114 名（95%）可进行主要结局分析。PRP 组在 12 个月时的 KOOS4 评分平均为 78.3（标准差，12.0；95%置信区间，75.2-81.4），对照组为 76.8（标准差，11.9；95%置信区间，73.7-79.9）（调整后的组间差异平均值，2.0；95%置信区间，-2.3 至 6.3；P = .36）。除了运动和娱乐水平以及 6 个月时的移植物成熟度外，两组的次要结局均无统计学差异。与干预相关的不良事件包括注射部位疼痛和注射后膝关节肿胀。
结论和相关性：在这项针对接受 ACLR 的患者的随机临床试验中，与不进行术后关节内 PRP 注射相比，术后关节内注射 PRP 并未在 12 个月时导致膝关节症状和功能的显著改善。需要进一步的研究来确定 PRP 在肌肉骨骼疾病中的合适适应证。
试验注册：中国临床试验注册中心标识符：ChiCTR2000040262。
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